BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT LG+ 10MM

    MDR report key: 2251884 · Received September 16, 2011

    Report

    Report Number
    1818910-2011-18341
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    September 6, 2011
    Report Date
    March 27, 2026
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    NJL
    PMA / PMN Number
    P830055/S116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT THEN HAD ENORMOUS SWELLING AND ONGOING PAIN AND STIFFNESS. THE POLY WEAR WAS VERY ALARMING AFTER ONLY 4 MONTHS OF IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMP RP INSERT LG+ 10MM KNEE NJL DEPUY RAYNHAM E55DH4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention